483
IVF-PGD LAB LLCIVF-PGD LAB LLC – FDA 483, Feb 13, 2019
Record Details
An FDA inspection of IVF-PGD LAB LLC in Chicago, IL, identified one observation related to the labeling of human cells, tissues, and cellular and tissue-based products (HCT/Ps). The firm failed to prominently label cryopreserved semen donor files with appropriate warning statements when donor eligibility determinations had not been performed. This indicates a deficiency in HCT/P labeling practices.
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- Chicago District Office
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